1、Submission Type
2、Cover Letter / Letters of Reference
3、Submitter Information
4、Pre-Submission Correspondence & Previous Regulator Interaction
5、Consensus Standards
6、Device Description
7、Proposed Indications for Use (Form FDA 3881
8、Classification
9、Predicates and Substantial Equivalence34
10、Design/Special Controls, Risks to Health, and Mitigation Measures
11、Labeling
12、Reprocessing
13、Sterility
14、Shelf Life
15、Biocompatibility
16、Software/Firmware
17、Cybersecurity/Interoperability
18、Electromagnetic Compatibility (EMC), Electrical, Mechanical, Wireless and Thermal Safety
19、Performance Testing
20、References
21、Administrative documentation
22、Amendment/Additional Information (AI) response
更多美国FDA医疗器械产品注册备案常见问题及方案解决请联系深圳市思博达彭先生或登录公司网站www.bccgd.com。